GLEPTOSIL- gleptoferron injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLEPTOFERRON (UNII: 898723IQHQ) (GLEPTOFERRON - UNII:898723IQHQ)

Available from:

Ceva Sante Animale

Administration route:

INTRAMUSCULAR

Prescription type:

OTC

Therapeutic indications:

INDICATIONS Gleptosil® (Iron 200 mg/mL Solution for Injection) is a haematinic for the prevention and treatment of iron deficiency anaemia in piglets. Piglets born and reared under intensive conditions may be deficient in iron and rapidly become anaemic. Unless these piglets receive supplemental iron early in life they are prone to suffer decreased vitality, poorer growth rates and increased susceptibility to disease. Gleptosil® (solution pour Injection de fer 200 mg/mL) est un hématinique pour la prévention et le traitement de l’anémie par carence en fer chez les porcelets. Les porcelets nouveauxnés, qui vivent sous des conditions intensives peuvent souffrir de la carence en fer et peuvent devenir rapidement anémiques. À moins que les porcelets reçoivent du fer supplémentaire tôt dans la vie ils sont susceptibles de souffrir des effets d’une vitalité diminuée, d’avoir un taux de croissance plus faible, et de présenter une susceptibilité accrue à la maladie.

Product summary:

PRESENTATION 100, 250 mL vials. Ceva Animal Health Inc., 6-1040 Fountain St. N., Cambridge, ON, N3E 1A3, 1-800-510-8864. ® Registered trademarks of Ceva Santé Animale. PRÉSENTATIONS Flacons de 100, 250 mL. Ceva Animal Health Inc., 6-1040 Fountain St. N. Cambridge, ON, N3E 1A3, 1-800-510-8864. ® Marque déposée de Ceva Santé Animale.

Authorization status:

unapproved drug other

Summary of Product characteristics

GLEPTOSIL- GLEPTOFERRON INJECTION
CEVA SANTE ANIMALE
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CLIENT INFORMATION
Client Information about
GLEPTOSIL® (IRON 200 MG/ML SOLUTION FOR INJECTION)
For Use in Pigs
The Client Information Sheet contains important information about
Gleptosil®. This sheet of
information is provided only as supplemental information to the
package insert. For more detailed
information about Gleptosil®, refer to the product package insert.
Gleptosil® is a presentation of gleptoferron, a macro molecular
complex containing iron in a readily
utilizable form for the prevention and treatment of iron deficiency
anemia in piglets. The solution
contains phenol as a preservative.
Gleptosil® is not an approved drug product in the U.S. Gleptosil® is
currently authorized for sale in
Canada. Due to a potential animal drug shortage, the U.S. Food and
Drug Administration is temporarily
permitting marketing of Gleptosil® in the U.S. for prevention or
treatment of anemia in baby pigs.
TO REPORT A SUSPECTED ADVERSE REACTION, COMPLAINT OR PRODUCT QUALITY
DEFECT, CALL CEVA’S PRODUCT
SUPPORT TEAM AT 1-800-999-0297. For additional information about
adverse drug experience
reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
www.fda.gov/reportanimalae.
MARKETED BY:
Ceva Biomune
Lenexa, KS 66215
1-800-999-0297
Gleptosil® is a registered trademark of Ceva Santé Animale.
DESCRIPTION
DIN 02245952
Veterinary Use Only
Usage vétérinaire seulement
GLEPTOSIL®
Iron Dextran Complex
Injection 200 mg/mL
Injection de complexe de
fer-dextran à 200 mg/mL
Gleptosil® is a presentation of gleptoferron, a macro molecular
complex containing iron in a readily
utilisable form for the prevention and treatment of iron deficiency
anaemia. The solution contains phenol
(Ph.Eur.) as a preservative.
Gleptosil®, une préparation de gleptoferron, est un complexe
macromol�